Last update: 27/09/2011  12.05

NGR-hTNF is a first-in-class compound based on the combination of a tumour homing peptide (NGR) with the human Tumour Necrosis Factor (hTNF). The resulting molecule has unique activity, including a direct biological antitumour activity and an increase of vascular permeability, thus making NGR-hTNF particularly attractive both as novel single agent therapeutic option, and as a part of a combination therapy with most chemotherapy regimens. 
 
Clinical trials of NGR-hTNF as single agent include:
- ongoing Phase III in mesothelioma as second-line treatment
- ongoing randomised Phase II in mesothelioma as first-line maintenance treatment
- completed Phase II in mesothelioma, colorectal cancer and liver cancer
- ongoing Phase I at high doses 

Clinical trials of NGR-hTNF in combination therapy include:
- ongoing randomised Phase II in non-small-cell lung cancer, with cisplatin-based regimens
- ongoing randomised Phase II in soft tissue sarcomas, either with doxorubicin or as monotherapy
- ongoing randomised Phase II in ovarian cancer, with pegylated liposomal doxorubicin (PLD)
- completed Phase II in small-cell lung cancer and in ovarian cancer, with doxorubicin
- completed Phase II in colorectal cancer, with Xelox

NGR-hTNF was granted Orphan Drug designation in the European Union and in the United States:
- in 2008 for the treatment of mesothelioma (EU/3/08/549)
- in 2009 for the treatment of liver cancer (EU/3/09/686)

Results of clinical trials